Go-to-Market Strategies
It’s time for some new thinking Make your choice!
“We see a market in transition this year, where pricing and policy pressures, including the continued implications of Most Favored Nation (MFN) frameworks, are converging with rapid advancements in data, AI, and evolving distribution models.
We from axxessive evaluate and develop integrated end-to-end solutions across the whole product lifecycle and patient journey in a new way:
- More integrated approaches across access, commercial, and patient strategy
- Greater focus on translating data and evidence into actionable, value-driven decisions
- Evolving go-to-market models and investment decisions across the launch lifecycle
- New thinking around distribution, affordability, and access strategy
We can no longer think in terms of US, ROW, or individual countries; strategies must be global, and fresh thinking is key.”
Strategic Go-to-Market Consulting
Planning to take your first steps outside of your home market?
axxessive is a strategic Go-to-Market partner providing emerging US, European, Chinese and Asian biotechs with the knowledge required to plan and build presence in international markets.
Detailed landscape analyses to determine an asset’s potential value — population, competition, HTA potential, price.
Key international market launch sequencing to optimize global ROI in a world with MFN.
Comprehensive P&L planning with FTE and investment requirements across functions and countries.
Board-ready Go-to-Market plans — Building, Named Patient / Early Access Programs, Partnering / Licensing, Financing, or a combination of approaches.
axxessive services are uniquely integrated with the key priorities of startup or growing organizations to build a regional or global commercialization platform.
Four pathways — or any combination
Build-out
Harvey & Nagl Health, 42health, subrosa Health together can define the optimal structure, resource requirements and support build-out in core markets — finding the right talent, interim support and HR / Payroll services.
Build-outEarly Access
Leavenoone, a global partner for Named Patient, Early Access / Compassionate-Use Programs. Customized architectural solutions combined with KOL-engagement and patient identification, precisely calibrated to distinct Regulatory & Payer Environments.
No authorizationPartnering
subrosa Alliances — assessment & contracting, licensing / distribution partner, alliance management.
PartneringFinancing
subrosa Capital provides financing support to emerging biotechs. subrosa Capital & axxessive together can support investment cases and finance them.
Financingaxxessive Seamlessly Integrates into subrosa’s global Solutions
Originator’s HQ
we bridge your gaps
own Medical & Commercial Structure, Team Building, Launch & Lifecycle Management.
EAP-Regulatory Strategy, Project Planning, Implementation, KOL-Engagemt, Patient identification
Assessment & Contracting Licensing / Distribution partner Alliance-Management
axxessive is the strategic partner for startups and companies planning to take their first steps outside of their home market.
subrosa Capital supports early startups with CXO-services and fundraising. subrosa OmicsAI evaluates, validates and publishes the real market size in case of genetic-based rare disease.
Between Phase I and Phase II trials, it’s the right time to plan study strategy and patient recruitments (subrosa OmicsAI) and to define the global go-to-market strategy — covering your asset’s potential value, launch sequencing, pricing, resource & P&L-planning, and Board-ready GTM scenarios across the three primary commercialization pathways: Core markets, EAP markets and Partnering markets. axxessive can guide you through each of them.
subrosa Group’s distinctive strength lies in our capacity to execute all three scenarios to-the-end, fully integrated from one source to bridge your gaps and fast-track your launch.
Your bridge to international
axxessive provides the bridge to international for US, European & Chinese biotech.
axxessive are the catalyst that new organizations need to take their first steps outside of their home market. axxessive expertise has supported numerous companies establish foundations and build for success.
Reliable access & commercial insights and solutions
Our industry experts provide the insights, analysis and validation to support companies to plan and execute their expansion goals.
Superior Expert Analysis
Insightful interpretation powered by industry insights.
Validation
Strong payer network blended with practical day-to-day experience.
axxessive recommendations
Informing your most important choices, investment decisions and hiring choices.
What we cover
and strategy
pressure testing
for licensing and M&A
The chronic microcap trap
Higher market capitalization for companies that build their own launch paths vs. those that routinely license out.
Pre-commercial biotech companies face a familiar strategic crossroads: launch independently or partner with a larger pharmaceutical company. As C-suite leaders weigh the trade-offs, one factor consistently rises to the top — the impact this decision will have on both current and future market valuation.
The core question is this: how much of a valuation premium does the market assign to companies that choose to launch independently, at least in the US? Public companies that have built their own launch paths — including both strong and sub-optimal launches — often show market capitalizations more than six times higher than peers that routinely license their products to other pharma companies. An independent launch can be prohibitively expensive and complex… or it can be the way out of the valuation trap. But it’s rarely straightforward.
Europe, as the world’s second-largest pharmaceutical market, is naturally attractive — yet not always commercially viable. The 30+ markets across Europe and EMEA have become increasingly challenging in recent years: more restrictive patient and market access, smaller patient populations, and high operational complexity. For biotechs without regional presence or experience — and with budgets constrained by heavy R&D investment and conservative public-market valuations — the hurdle is even higher. As a result, more originators are choosing not to launch their (orphan) medicines in EMEA at all, or are withdrawing from parts of the region. This is suboptimal for patients, for valuation, and for exit scenarios. It’s time for a different approach.
This is where subrosa health comes in. With a strategic, long-term partnership mindset, we work with early- to late-stage biopharmaceutical originators to create tailored, win-win commercialization pathways for launching in EMEA.
Selected axxessive market access engagements
Click a case study to explore the detail
How we developed a Go-to-Market Plan Europe for a US biotech startup EU Commercialization & Market Access Strategy — a US biotech with a NASH / MASH asset.
Client & Goals
Context: Cardio-Metabolic MASH asset.
Goal:
- Develop a robust, board-ready EU Go-to-Market strategy
- Quantify the European opportunity (population, price, HTA, IRP)
- Define launch sequencing & investment roadmap
- Reduce risk and maximize asset valuation
Methods
Systematic Go-to-Market Framework
- Landscape & External Insights: Payer & clinician, HTA strategy assumptions, epidemiology & patient pathway analysis
- Forecast: Country-level P&L forecasts, pricing corridors & global IRP evaluation (incl. MFN), market prioritization
- Execution Planning: EU launch sequence, investment & organization build-out, FTE & timeline planning
Results
- Clear country prioritization, launch sequence
- Country-specific HTA plan & pricing visibility
- Integrated international P&L forecast
- Board-ready decision framework for launch with options for partnering, go-it-alone and hybrid scenarios
Outcome
- Approval by the board for EU5 + 6 additional countries, to establish affiliates and initiate sequential recruitment
- Initiation of Regulatory and HTA processes
- Financial plan with clear milestones
Supporting early patient access Options for early access across international markets that support HTA; free of charge and income generation.
Client & Goals
Context: Rare disease biotech organization with FDA Fast Track and the potential for a conditional approval.
Goal:
- Explore options for early patient access
- Quantify the opportunity for paid and unpaid access
- Understand the impact of early access on future HTA and pricing scenarios
- Gain clarity on the impact of early trial termination and the ongoing evidence generation requirements
Methods
Assessing the opportunity: Early access balances unmet need, regulatory requirement and HTA success.
- Unmet Need: Evaluate the options to move forward with early access and/or apply for conditional approval
- Assess the requirements and processes for each market; paid and unpaid
- Understand the potential impacts (+/–) of charging for programs to determine if Named Patient, EAP or conditional approval is optimal
Results
- A recommendation to pursue a conditional approval ex-US
- Clear pricing and payer feedback supporting the case for early engagement
- A fully costed P&L across key markets with a phased budget to support investment planning across all key functions
Outcome
- Patients gained access to treatment 3 years earlier than originally planned
- Advancing the launch of a rare disease asset by >2 years, supported by earlier-than-planned engagement with regulators
- A price-setting strategy that minimizes external threats from competition and factors such as MFN
Navigating complex market dynamics in a market with competition A generic approach to market expansion is no longer appropriate.
Client & Goals
Context: Rare disease biotech organization with an ODD in a competitive market segment.
Goal:
- Launch new asset across international markets
- Retain pricing discipline to avoid negative global price referencing
- Navigate the challenges of generics and category price comparisons
Methods
Assessing the opportunity for each market, then assessing international referencing impacts
- Landscape assessment to evaluate the current market dynamics and unmet need
- HTA and pricing assessments by country, including appropriate comparators and national processes
- Define an estimated pricing corridor and validate with external expertise
- Prioritize country opportunities based upon price, population and international impact
Results
- A recommendation to pursue a sub-group of countries and clusters — a non-classical build-out option
- ‘Park’ countries with high-risk profiles that could be pursued if market conditions changed
- A fully costed and timed launch template for Board approval
Outcome
- Agreement to pursue a build-out with an EU hub, 3 stand-alone countries, 1 country cluster and several distributor regions
- A plan for commercialization in second-tier markets, ready to proceed quickly
Developing the Go-to-Market plan in 3 phases
When developing the EU Go-to-Market model, it is recommended that all ‘potential’ markets in scope are evaluated. This will support a clear understanding of the local HTA strategy, the size of the potential population, a European forecast, launch sequencing and resource planning.
Inside each phase
Phase 1 — Landscape and external insights.
HTA Insights
- National HTA strategy assumptions: HTA routing, expected HTA rating, price band expectation
- Identification of potential risks / opportunities for each market
- HTA Roadmap with indicative impact upon EU sequence
Payer & Clinician Insight
- Appraisal or validation of clinical trial evidence and additional requirements
- Clinical insights empower companies to understand the burden of disease, treatment patterns and unmet need
- Payer insights provide an evaluation of potential HTA outcomes and price levels
Market Potential
- Patient population by population and estimated under-treated care
- Patient pathway, current diagnosis criteria and anticipated diagnosis post-launch
- Initial market prioritization (price / volume) overview
- Market categorization — high, med, low priority and no-go
Phase 2 — Evaluation: building a robust picture of the European opportunity.
Strategic outputs from Phase 1
- HTA submission strategy (and option) in each market
- Predictability of HTA outcomes, price bands and routes to market for each country (retail, hospital) + price transparency
- Country-specific evidence requirements
- Insights how payers and clinicians evaluate the asset
- Scenarios on speed to market, uptake and peak revenues
- Pricing corridor potential revenues in Europe
Additional inputs supported by client
- National epidemiology
- Demand forecast, market share assumptions and CoGs etc.
Forecasting
- Commercially available patients
- Country prioritization — population vs. price potential
- Profit & loss forecasts developed for each market as a ‘stand-alone’ — in the next phase, the launch sequence, prioritization and price referencing will be applied
Taking the outputs from Phase 1 (HTA, F-Popn, patient pathway and price band) and combining them with client assumptions to create an EU P&L forecast.
Phase 3 — Execution Plan: Strategy, Investment and Build-out plan.
G-t-M Strategy
- European Launch Sequence
- Regulatory (incl. UK / CH IRP options) and HTA timelines considering optimal reference pricing cascade
- HTA Roadmap with risks / opportunities
- IRP — international reference pricing
Investment Plan
- Region Europe and / or Key Market P&L
- P&L built from a country level with forecast revenue and costs
- Granularity and the ability to look at different scenarios
- Adaptable to include additional countries as required
Organization Build Plan
- International Organizational Build
- Country-based FTE requirements and profiles
- Central support requirements
- Externalized or temporary resource needs
Forecast model G-t-M Strategy, Roadmap & Sequence
A realistic launch sequence and market prioritization will be developed based on market insights, likely HTA outcomes, population size, price potential and IRP considerations. Other considerations may include speed to market, early access opportunities and the regulatory landscape.
Utilizing insights from the landscape analysis, we can develop a 10-year forecast model to support decision-making around the go-to-market strategy. The model will capture the P&L perspective (investments vs pricing), likely country HTA outcomes and price potential considering indication-specific pricing. The model will also include a scenario analyzer which enables the ability to explore and adjust assumptions.
Final profit & loss forecasts will be augmented with launch sequence, country configurations and costs to inform the go-to-market strategy.
Deliverable: Forecast model (Excel)
The launch sequence will be developed for the indications (F2/F3 and F4 can be included)
Country configurations and cost efficiencies will be recommended to maximize operating profit
Countries will be categorized into tiers based upon potential
G-t-M Strategy
- Country launch sequence based upon potential and IRP
- HTA Roadmap and timelines
Investment Plan
- Financial milestones – break-even (by country, region)
- Investment Roadmap by countries & key functions
Organization Build Plan
- FTE requirements and profiles by country / region
- Timelines and ‘gating’ vs. critical milestones
IRP – international reference pricing
Approximately 12–16 weeks across a 3-stage approach
The timeline will be over an approximate 12–16 week period over a 3-stage approach.
Built for speed
We don’t promise what we might not be able to keep.